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Fetal Pillow insertion for Breech Birth

N/A
Waitlist Available
Led By David A Hill, MD
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient speaks English or Spanish as primary language.
Patient able to understand verbal and written consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after ecv procedure or during subsequent labor and delivery
Awards & highlights

Study Summary

This trial is testing a balloon device to help turn breech babies during pregnancy. The device is placed under the baby's bottom to help lift it during the procedure.

Eligible Conditions
  • Breech Birth
  • External Cephalic Version

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient arrival to labor unit for ecv procedure and discharge home (up to 72 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and patient arrival to labor unit for ecv procedure and discharge home (up to 72 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful external cephalic version
Secondary outcome measures
Cesarean delivery
Cost of ECV procedure and hospital stay (mother)
Cost of ECV procedure and hospital stay (neonate)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Inflation of the balloon device
Group II: ControlPlacebo Group1 Intervention
Non-inflation of the balloon device

Find a Location

Who is running the clinical trial?

AdventHealthLead Sponsor
105 Previous Clinical Trials
29,200 Total Patients Enrolled
Ariana MoraStudy DirectorAdventHealth
David A Hill, MDPrincipal InvestigatorAdventHealth
1 Previous Clinical Trials
120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this research?

"The information available on clinicaltrials.gov indicates that this research endeavour is still recruiting patients, having first been posted in November of 2020 and last modified September 30th 2022."

Answered by AI

How many individuals have been accepted into this clinical trial thus far?

"Affirmative. The details posted on clinicaltrials.gov confirm that enrollment for this study is still open and actively seeking participants, as it was first published on November 1st 2020 with the most recent update taking place September 30th 2022. Currently 92 individuals are required to join at a single medical facility."

Answered by AI
Recent research and studies
~3 spots leftby Mar 2025